BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    NON-KOR ACCESS KITS

    K Number: K852831 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    79

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    Basic Information

    Device Name
    NON-KOR ACCESS KITS
    K Number
    K852831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Creative Care Systems, Inc.
    Date Received
    July 2, 1985
    Decision Date
    September 19, 1985
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Creative Care Systems, Inc.

    K Number Device Name
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    K850887 DRESSING CHANGE KIT
    K841742 NON-CORING NEEDLE
    K840919 DAYPAK SYS VII CATHETER CARE KIT
    K840681 DAYPAK SYSTEM III CATHETER CARE KIT